Medico-surgical tube assemblies

ABSTRACT

A tracheostomy tube assembly has a flange arrangement ( 2 ) movable along the shaft ( 1 ) of the assembly and lockable at different positions. The flange arrangement has a gel-filled member ( 22 ) with a flexible conformable surface ( 26 ) providing substantially the entire surface contacting the skin. The flange has aperture ( 28 ) through which a tape can be extended for use in securing the assembly with the patient&#39;s neck. The gel-filled member ( 122 ) may be provided separately for use on existing tube assemblies.

This invention relates to medico-surgical tube assemblies of the kindincluding a tubular shaft arranged to extend within the body via anopening and a flange arrangement mounted with the shaft and having asurface adapted to contact the external skin surface of the patient.

Medico-surgical tubes, such as tracheostomy tubes, are commonly providedwith a flange to secure the tube to the patient's body. In the case of atracheostomy tube, the flange is positioned close to the surface of theneck where the tube enters the tracheostomy, a tape is threaded throughopenings in the flange and fastened around the neck. Tracheostomy tubesmay be worn for prolonged periods and the contact of the flange on thedelicate skin of the neck around the tracheostomy can cause discomfortand irritation. This is a particular problem with freshly formed stomas.

There are other medico-surgical tubes with flanges having a similarproblem.

It is an object of the present invention to provide an alternativemedico-surgical tube assembly.

According to one aspect of the present invention there is provided amedico-surgical tube assembly of the above-specified kind, characterisedin that the skin-contacting surface is provided by a gel-filled memberarranged to contact the skin.

The gel-filled member preferably provides substantially the entiresurface contacting the skin. The flange arrangement may include an outerflange, the gel-filled member being located between the outer flange andthe skin surface. The gel-filled member may be provided as a separatecomponent from the outer flange. Alternatively, the flange arrangementmay be provided by a flange containing a gel substance and having aconformable skin-facing surface. The conformable skin-facing surface maybe provided by a thin wall of a flexible plastics material. The flangemay include a plurality of gel-filled members. The flange arrangementmay include an outer flange, a gel-filled member having a surfaceadapted to contact the patient's skin surface and a gas-filled memberlocated between the outer flange and the gel-filled member. Thegas-filled member is preferably inflatable.

According to another aspect of the present invention there is provided atracheostomy tube assembly including a tubular shaft arranged to extendwithin the trachea via a tracheostomy and a flange arrangement mountedwith the shaft and extending laterally on opposite sides of the shaft,the flange arrangement having a surface adapted to contact the externalskin surface of the neck of the patient and provided with apertures toreceive a tape used to secure the assembly with the patient's neck, theskin-contacting surface being provided by a gel-filled member arrangedto contact the skin.

The gel may be a silicone material or hydrogel. The flange arrangementmay be movable along the shaft.

According to a further aspect of the present invention there is provideda gel-filled component for a tube assembly of the kind including atubular shaft arranged to extend within the body via an opening and aflange mounted with the shaft and having a skin-facing surface,characterised in that the gel-filled component is slidable along theshaft to be positioned between the skin-facing surface of the flange andthe patient's skin, and that the gel-filled component provides aconformable surface arranged to contact the patient's skin in use.

Several examples of different forms of tracheostomy tube assemblyaccording to the present invention will now be described, by way ofexample, with reference to the accompanying drawings, in which:

FIG. 1 is a side elevation view of the machine end of a first form oftube assembly;

FIG. 2 is a perspective view of machine end of the assembly of FIG. 1;

FIG. 3 is an end view of assembly at the machine end;

FIG. 4 is a cross-section view across the flange of the assembly alongthe line IV-IV of FIG. 3;

FIG. 5 is a side elevation view of the machine end of an alternativeassembly where the flange assembly includes a plastic flange and aseparate gel-filled flange located between the plastic flange and theneck surface;

FIG. 6 is a perspective view of the gel-filled flange of the arrangementof FIG. 5;

FIG. 7 is a perspective view of a third tracheostomy tube assembly; and

FIG. 8 is a perspective view of a fourth tracheostomy tube assembly.

With reference first to FIGS. 1 to 4 there is shown the machine end of afirst form of tracheostomy tube assembly comprising a tubular shaft 1and a flange arrangement 2 mounted on the shaft. The shaft 1 is entirelyconventional, being extruded or moulded of a plastics material and beingcurved along its length to an appropriate anatomical shape. The patientend of the shaft (not shown) may be provided with a conventionalinflatable sealing cuff or it may be plain. The machine end 10 of theshaft 1 is terminated by a luer-tapered coupling 11 of conventional kindbonded with the end of the shaft. The flange assembly 2 is movable alongthe shaft 1 and is lockable in any desired position, althoughalternative embodiments could have a flange that is fixed in positionrelative to the shaft. The flange assembly 2 of the present embodimentincludes a rear locking clamp 20, preferably of the kind described inWO08/003929. The clamp 20 includes a rotatable arm 21, which is swungdown to the position shown in FIGS. 2 and 3 to cause the clamp to gripthe outside of the shaft 1. The clamp 20 is mounted on the rear face ofa forward component 22 providing two elongate wings 23 and 24 extendingoutwardly from a central disc 25. The wing component 22 includes anouter wall 26 of a relatively thin, flexible plastics material such aspolyurethane or urethane enclosing a filling of a gel material 27, asmost clearly shown in FIG. 4. The gel material 27 may be of anyconventional medical grade gel, such as ComfortGel sold by Respironics,a silicone or hydrogel, or a gel of the kind described in U.S. Pat. No.6,631,718. The thin nature of the wall 26 and the gel filling 27 makethe flange wings 23 and 24 highly flexible, conformable and soft. Theflange wings 23 and 24 each have an aperture 28 towards their outer endsthrough which is threaded a tape or the like used to secure the tubeassembly in position about the neck of the patient. In use, the skinaround the stoma is contacted by the forward surface 29 of the wingcomponent 22, the soft nature of the flange ensuring that it conformsclosely to the anatomy, thereby distributing pressure evenly, producinga good fit and ensuring excellent patient comfort.

Instead of making the flange itself of a gel-filled material, thepresent invention enables conventional tracheostomy tubes to be modifiedin the manner shown in FIGS. 5 and 6. In this embodiment, a gel-filledcomponent 122 with a central disc 125 and two wings 123 and 124 isprovided as a separate component, which can be slipped onto the shaft101 and slid into position on the forward side of a conventional solidplastics outer flange 130. In this way it acts as a conformable pillowbetween the flange and the patient's skin and provides a conformableskin-contacting surface 126.

In both these arrangements, the entire contact with the patient's skinsurface is by a gel-filled component.

FIG. 7 shows a third embodiment where a tracheostomy flange 222 is of asolid plastics material but includes within it gel-filled regionsadapted to contact the skin surface. As shown, in this example, eachwing 223 and 224 includes two circular apertures 226 formed through itand each containing a circular insert 227 in the form of a pillow havinga flexible plastics wall enclosing a gel filling. The pillows 227 eachproject slightly beyond the forward and rear surfaces of the wings 223and 224 so that the major contact of the flange with the skin is via thegel-filled pillows.

The fourth arrangement shown in FIG. 8 is similar to the arrangement ofFIGS. 5 and 6 except that the outer plastics flange 330 includes aninflatable air sack 331 on its forward facing surface and a gel-filledflange 332 on the forward surface of the air sack. The air sack 331 canbe inflated or deflated as desired to provide the best possible fit tothe patient's anatomy. The inflatable air sack 331 may be similar to thearrangement described in U.S. Pat. No. 4,649,913.

1-13. (canceled)
 14. A medico-surgical tube assembly including a tubularshaft arranged to extend within body of a patient via an opening and aflange arrangement mounted with the shaft and having a skin-contactingsurface adapted to contact the external skin surface of the patient,characterized in that the tube assembly includes both an outer flangefor use in securing the assembly with the body and a gel-filled memberprovided as a separate component from the outer flange and adapted to belocated between the outer flange and skin of the patient to provide aconformable surface in contact with the skin and that the tubular shaftextends through both the outer flange and the gel-filled component wherethe tubular shaft extends into the body via the opening.
 15. An assemblyaccording to claim 14, characterized in that the skin-contacting surfaceof the gel-filled member is provided by a thin wall of a flexibleplastics material.
 16. An assembly according to claim 14, characterizedin that the flange arrangement includes a gas-filled member and islocated between the outer flange and the gel-filled member.
 17. Anassembly according to claim 16, characterized in that the gas-filledmember is inflatable.
 18. A tracheostomy tube assembly including atubular shaft arranged to extend within a patient's trachea via atracheostomy and a flange arrangement mounted with the shaft andextending laterally on opposite sides of the shaft, the flangearrangement having an outer flange provided with apertures to receive atape used to secure the assembly with the patient's neck surface,characterized in that the flange arrangement includes in addition to theouter flange used to secure the assembly with the patient's neck surfacea gel-filled member provided as a separate component from the outerflange and adapted to be located between the outer flange and externalskin surface of the patient's neck to provide a conformable surface incontact with the skin and that the tubular shaft extends through boththe outer flange and the gel-filled component where the tubular shaftextends into the patient's body via the opening.
 19. An assemblyaccording to claim 18, characterized in that the gel is a siliconematerial or a hydrogel.
 20. An assembly according to claim 18,characterized in that the flange arrangement is movable along the shaft.21. A lockable flange for selective positioning at different locationsalong a tracheostomy tube, wherein the flange includes a wing member ofa relatively stiff plastics material, wherein the wing member isconfigured to extend laterally of the tracheostomy tube and has anopening at opposite ends adapted to receive a neck tape used to securethe tube around neck of a patient, wherein the flange includes agel-filled component comprising a thin wall of flexible plasticsmaterial and a filling of a gel material, the gel-filled component beingarranged for positioning on the tube between the wing member and necksurface of the patient, wherein the tracheostomy tube extends throughboth the flange and the gel-filled component where the tube extendsthrough the neck surface into trachea of the patient, and wherein theflange includes a releasable lock that retains the flange in position atthe selected location on the tube when locked and enables the flange tobe moved along the tube to a different location when released.